220016
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
体外诊断测试试剂/试剂盒，血清学，病毒，严重急性呼吸综合征冠状病毒2型，抗原
SD Biosensor, Inc.·C·Hong Kong MDACS·Registered January 20, 2022Delisted
Device overview
- Risk class
- C
- Product code
- 41618
- State
- N/A
- Status
- Delisted已退市
- Brand
- Roche罗氏
Manufacturer (製造商)
- Name
- SD Biosensor, Inc.Sd Biosensor,Inc.
- Address
- C-4th&Sth, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC OF KOREA韩国京畿道水原市龙塘区德京大路1556便路16号，C-4栋&S栋，邮政编码16690
Authorised representative (AR)
- Phone
- 24813387
Regulatory timeline
- Registration date
- January 20, 2022
- Expiry date
- January 20, 2027
- Delist date
- July 08, 2024
Product models
SARS-CoV-2 Antigen Self Test Nasal (9901-NCOV-06G)
Remarks
Delisted.
已從列表中刪除。
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
產品資訊： 体外诊断测试试剂/试剂盒，血清学，病毒，严重急性呼吸综合征冠状病毒2型，抗原